Long-term Self-balancing Exoskeleton Rehabilitation to Treat Lower Limb Weakness And/or Impairments in Adult Population: A Feasibility Study

Research Objectives: To investigate the effects of long-term rehabilitation with Atalante exoskeleton in patients with lower limb weakness and/or impairments, regardless of etiology, on seated postural control, functional capacities, and safety.

Design: Interventional, national, prospective, open study, with before-after trial design, each participant serving as their own control.

Setting: Wandercraft Walk-in-Paris gait research center, Paris, France.

Participants: 100 adults diagnosed with lower limb weakness and/or impairment will be included. Exclusion criteria encompass severe spasticity, osteoporotic fractures, pressure ulcers, and device-specific morphological contraindications. 12 included participants, diagnosed with (in)complete spinal cord injury (T9- to-L1 level, n=6), multiple sclerosis (n=3), post-radiation radiculoplexopathy, congenital teratoma, and stroke; for 12 ± 9.1 years, have completed the 4-months assessment milestone.

Interventions: One-year exoskeleton rehabilitation weekly sessions, with assessments scheduled at baseline, after 4 months, and after a year of rehabilitation.

Main Outcome Measures: Primary outcome was assessed with Function in Sitting Test (FIST). Secondary outcomes included evaluating functional capacities such as endurance assessed through 6-minute walked/wheeled test (6MWT), and safety monitored through adverse events occurrence. Rehabilitation sessions were tracked by verticalization duration, number of steps performed, and average device assistance.

Results: Patients underwent 9.4 ± 3.4 exoskeleton rehabilitation sessions over 4 months, with average verticalization duration of 40.5 ± 10.5 minutes, 721 ± 252 performed steps and 31.7 ± 28.3% average device assistance. The results suggest significant improvements in seated postural control and endurance, as measured by FIST and 6MWT, respectively. Six adverse events were reported, only one non-serious event being directly related to the device, all resolved without sequelae.

Conclusions: Preliminary findings indicate that rehabilitation with Atalante is safe and show promising results in improving seated postural control and endurance among adults with lower limb weakness and/or impairment. Further investigation is necessary to conclusively determine its clinical effectiveness.

Author(s) Disclosures: Authors are Wandercraft employees involved in the design of the device, collection, analysis, and interpretation of data.